GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).

DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable genetic disorder.

On 3/20/2025, "URGENT MEDICAL DEVICE RECALL" notices dated 3/20/2025 were emailed to customers who were asked to do the following: 1. Please check your inventory and identify if you have the affected product. 2. Confirm the number of affected kits in your possession and discard any unused kits. 3. Inform those who need to be aware of this notification within your organization or any other organization to which the affected product(s) have been transferred. Please ensure that your organization maintains awareness of this notice. 4. Complete and return the acknowledgement form via email to [email protected] This issue is limited only to chromosome 12, and the data generated can be analyzed using the CytoDx functionalities by displaying the moving average line in the Genome View, Chromosome View, or Gene View of the Triage View. If you have any questions, contact Agilent Technologies, Inc. via email: [email protected] or call 408-386-7294.